Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial.

ABSTRACT:

Background

A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated.

Methods/design

The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographi

SUBMITTER: Seidel D 

PROVIDER: S-EPMC4225503 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature